Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction

A new, simple and sensitive HPLC method was developed for the quantification of raloxifene in rat plasma. Samples were prepared by liquid- liquid extraction method together with diclofenac sodium as internal standard (IS) at 2 μg/ml concentration. Separation of raloxifene from the treated samples wa...

Full description

Bibliographic Details
Main Authors:	Mahmood, Syed, Bakhtiar, M. Taher, Mandal, Uttam Kumar
Format:	Conference or Workshop Item
Language:	English
Published:	Kulliyyah of Pharmacy, International Islamic University Malaysia 2016
Subjects:	RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/51874/ http://irep.iium.edu.my/51874/ http://irep.iium.edu.my/51874/13/51874-new.pdf

id	iium-51874
recordtype	eprints
spelling	iium-518742016-09-26T08:09:30Z http://irep.iium.edu.my/51874/ Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction Mahmood, Syed Bakhtiar, M. Taher Mandal, Uttam Kumar RS Pharmacy and materia medica A new, simple and sensitive HPLC method was developed for the quantification of raloxifene in rat plasma. Samples were prepared by liquid- liquid extraction method together with diclofenac sodium as internal standard (IS) at 2 μg/ml concentration. Separation of raloxifene from the treated samples was performed in a thermo-fisher syncronis RP- C18 column (150mm x 4.6 mm, 5μm particle size) at room temperature with a mobile phase containing acetonitrile and phosphate buffer of pH 6.1 (34:66 v/v) at a flow rate of 1 min/ml and ultraviolet detection at 285 nm. The developed method was validated for specificity, linearity, precision, accuracy, stability, sensitivity and recovery. Good linearity was achieved in the range of 125 ng/ml to 10 μg/ml (R2 = 0.9994). Precision and accuracy were within the acceptable limit of ICH guideline. Raloxifene was stable in quality control (QC) samples subjected to three freeze thaw cycles. QC Samples were also stable for 12 hours at room temperature, 3 months stored in deep freeze at -200C, and 12 hours after their processing (extraction followed by reconstitution with the mobile phase). The Overall recovery of raloxifene from the plasma samples were found to be within a range of 75.18% to 88.95%. The developed method was sensitive enough (LOQ: 125 ng/ml) that can be used to determine the plasma concentration of raloxifene in a pharmacokinetic study involving rats. Kulliyyah of Pharmacy, International Islamic University Malaysia 2016-08 Conference or Workshop Item NonPeerReviewed application/pdf en http://irep.iium.edu.my/51874/13/51874-new.pdf Mahmood, Syed and Bakhtiar, M. Taher and Mandal, Uttam Kumar (2016) Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction. In: 2nd International Conference On Industrial Pharmacy 2016 (ICIP 2016), 15-16 August 2016, Kuantan, Pahang, Malaysia. (Unpublished) http://www.iium.edu.my/icip2016/
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English
topic	RS Pharmacy and materia medica
spellingShingle	RS Pharmacy and materia medica Mahmood, Syed Bakhtiar, M. Taher Mandal, Uttam Kumar Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction
description	A new, simple and sensitive HPLC method was developed for the quantification of raloxifene in rat plasma. Samples were prepared by liquid- liquid extraction method together with diclofenac sodium as internal standard (IS) at 2 μg/ml concentration. Separation of raloxifene from the treated samples was performed in a thermo-fisher syncronis RP- C18 column (150mm x 4.6 mm, 5μm particle size) at room temperature with a mobile phase containing acetonitrile and phosphate buffer of pH 6.1 (34:66 v/v) at a flow rate of 1 min/ml and ultraviolet detection at 285 nm. The developed method was validated for specificity, linearity, precision, accuracy, stability, sensitivity and recovery. Good linearity was achieved in the range of 125 ng/ml to 10 μg/ml (R2 = 0.9994). Precision and accuracy were within the acceptable limit of ICH guideline. Raloxifene was stable in quality control (QC) samples subjected to three freeze thaw cycles. QC Samples were also stable for 12 hours at room temperature, 3 months stored in deep freeze at -200C, and 12 hours after their processing (extraction followed by reconstitution with the mobile phase). The Overall recovery of raloxifene from the plasma samples were found to be within a range of 75.18% to 88.95%. The developed method was sensitive enough (LOQ: 125 ng/ml) that can be used to determine the plasma concentration of raloxifene in a pharmacokinetic study involving rats.
format	Conference or Workshop Item
author	Mahmood, Syed Bakhtiar, M. Taher Mandal, Uttam Kumar
author_facet	Mahmood, Syed Bakhtiar, M. Taher Mandal, Uttam Kumar
author_sort	Mahmood, Syed
title	Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction
title_short	Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction
title_full	Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction
title_fullStr	Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction
title_full_unstemmed	Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction
title_sort	development and validation of high performance liquid chromatography method for analysis of raloxifene hcl in rat plasma by liquid –liquid extraction
publisher	Kulliyyah of Pharmacy, International Islamic University Malaysia
publishDate	2016
url	http://irep.iium.edu.my/51874/ http://irep.iium.edu.my/51874/ http://irep.iium.edu.my/51874/13/51874-new.pdf
first_indexed	2023-09-18T21:13:32Z
last_indexed	2023-09-18T21:13:32Z
_version_	1777411411579764736

Development and validation of high performance liquid chromatography method for analysis of Raloxifene HCl in rat plasma by liquid –liquid extraction

Similar Items